Medical Device Manufacturer · US , San Jose , CA

Boston Scientific - FDA 510(k) Cleared Devices

61 submissions · 55 cleared · Since 2001

Recent clearances: Rezum System, AVVIGO™+ Multi-Modality Guidance System, EluPro Antibiotic-Eluting BioEnvelope

View 61 510(k) Devices ↓ Official Website

61

Total

55

Cleared

1

Denied

FDA 510(k) Regulatory Record - Boston Scientific Orthopedic ✕

1 devices

1-1 of 1

Cleared Mar 13, 2024

ICEfx Cryoablation System (FPRCH8000-02)

Orthopedic · 85d